Medical protective and exercise restraint systems and methods

ABSTRACT

Intended to prevent self-extubation of nasal or oral tubes of an awake patient who may reflexively attempt removal of such and allow the early mobilization and exercise necessary for preservation of as much muscle strength as possible, promotion of diaphragmatic motion necessary for liberation from a ventilator, reduction of patient stress allowing for sedation minimization and improved cognition for reduction of delirium and post-intensive care syndrome, and relief of medical staff and healthcare dollars to focus more on healthcare rather than on protection from self-harm.

RELATED APPLICATION DATA

This application claims the benefit of priority of U.S. ProvisionalPatent Application Ser. No. 62/205,298, filed on Aug. 14, 2015, andtitled “PROTECTIVE AND EXERCISE RESTRAINT SYSTEM FOR INTUBATEDPATIENTS,” which is incorporated by reference herein in its entirety.

FIELD OF THE INVENTION

The present invention generally relates to the field of medicalrestraining devices. In particular, the present invention is directed tomedical protective and exercise restraint systems and methods for, e.g.,intubated patients or patients who otherwise have indwelling tubes,lines, or catheters.

BACKGROUND

For intubated intensive care unit patients confined to a bed for anysignificant period of time, meaningful early mobilization and sedationminimization are key elements in reducing morbidity and mortality,hastening recovery and improving quality of life by preserving cognitionand strength. However, when breathing tubes, naso/orogastric tubes,intravenous (IV) lines and other medical devices are in place,preventing removal (e.g., self-extubation) of such devices can alsoreduce morbidity and mortality in, e.g., an intensive care unit (ICU).In order to prevent removal, restraints that drastically restrict thepatient's range of motion are often used and sedation is thenadministered to reduce the anxiety of being unable to move. Caregiverpersonnel are reluctant to loosen or remove restraints because of thedire consequences of premature medical device disconnection, therebypresenting a dilemma in balancing these competing concerns.

Various types of restraints have been employed in an attempt to permit areasonable range of motion while still protecting against device removalby the patient. However, existing restraint systems that do allow forreasonable motion still do not provide reliable or sufficient protectionagainst device removal, nor do they allow changeable and graded levelsof restraint to follow a patient's changing capabilities such that amandate of minimum patient restraint is continually followed. Forexample, mitt restraints are often ineffective as patients can stilldisconnect themselves by pressing the mitts together. In fact even withwrist restraints, if patients are awake, as is often desirable, they maybe able to move a tube they want to disconnect toward the tied handrather than the hand to the tube. Often this is done in a state ofstupor, but any further awakening of the patient can cause extremeanxiety with the realization that they are tied to a bed. Elbowimmobilizers or arm boards are also employed, but awake patients may beable to disconnect themselves from such restraints. The best restraintsare completely ineffective if an awake or semi-awake patient is able todisconnect them. Other problems with these types of restraints includeobscuring of potential IV sites, obstruction of full arm skinassessment, joint fixation, and nerve palsies. Creation or worsening ofpressure sores, which accounts for significant morbidity in theintensive care patient given that merely edema without device contactcan cause skin tears, is also a concern with any device that hascontinued contact with a patient's skin. Difficulties with existingsystems can burden ICU staff, who may be required to spend more timewatching one patient to the detriment of another and to theirdocumentation and medication dispersion duties.

SUMMARY OF THE DISCLOSURE

Disclosed embodiments help to prevent self-extubation of nasal or oraltubes and reduce the risk of removal of other indwelling lines andcatheters of an awake or semi-awake patient who may reflexively attemptremoval of such and allow the early mobilization and exercise necessaryfor preservation of as much muscle strength as possible, promotion ofdiaphragmatic motion necessary for liberation from a ventilator, andreduction of patient stress with multiple levels of restraint in betweentied and untied, allowing for sedation minimization and improvedcognition leading to reduction of the debilitating post-intensive caresyndrome (PICS) and complying with a minimum restraint necessarynationwide mandate while simultaneously minimizing dangerous skincontact and allowing full arm skin assessment and usage.

In one implementation, the present disclosure is directed to a medicalprotective and exercise restraint system. The system includes a rigidrestraining structure configured and dimensioned with a lengthsufficient to extend from a patient's hand to the patient's shoulderwith the patient's elbow unbent; a hand strap attached to therestraining structure adjacent the patient's restrained hand, configuredto be wrapped around the patient's hand or wrist; and a shoulder strapattached to the restraining structure adjacent the patient's shoulder,configured to be wrapped around the patient's upper arm or axilla,wherein the hand strap and shoulder strap constrict movement of thepatient's arm such that the patient is unable to touch the restrainedhand to their face. Attachments of the rigid restraining structure tothe patient consist of the shoulder strap and the hand strap with orwithout a thumb strap attached to the restraining structure adjacent thepatient's hand, wherein the thumb strap is configured and dimensioned toattach to the hand strap along the volar aspect of the patient's wristor hand, such that the patient's arm is not contacted by the systembetween the hand and shoulder straps. The rigid restraining structure isconfigured to bear against the patient only at two locations; a firstlocation from the bicep to the shoulder and a second location at thehand. The first location is at the shoulder and the second locationformed by a graspable member at the palm.

In another implementation, the present disclosure is directed to amethod of using a medical protective and exercise restraint systemincluding a rigid restraining structure, a hand strap attached to therestraining structure, and a shoulder strap attached to the restrainingstructure. The method includes wrapping the hand strap around apatient's hand or wrist, wrapping the shoulder strap around thepatient's arm or axilla, and positioning the restraining structure alongthe patient's arm such that the restraining structure extends from thepatient's hand to above the patient's shoulder, the restrainingstructure does not contact the patient, and the patient is unable totouch their hand to their face.

These and other aspects and features of non-limiting embodiments of thepresent invention will become apparent to those skilled in the art uponreview of the following description of specific non-limiting embodimentsof the invention in conjunction with the accompanying drawings.

DESCRIPTION OF DRAWINGS

For the purpose of illustrating the disclosed embodiments, the drawingsshow aspects thereof. However, it should be understood that the presentdisclosure is not limited to the precise arrangements andinstrumentalities shown in the drawings, wherein:

FIG. 1A is a schematic diagram of an exemplary protective and exerciserestraint system illustrating a top view of a dual slat embodiment;

FIG. 1B is a schematic diagram of an exemplary protective and exerciserestraint system illustrating a side view of the dual slat embodiment ofFIG. 1A;

FIG. 2A is a schematic diagram of an exemplary protective and exerciserestraint system illustrating a top view of a single slat embodiment;

FIG. 2B is a schematic diagram of an exemplary protective and exerciserestraint system illustrating a side view of the single slat embodimentof FIG. 2A;

FIG. 3 is a schematic diagram of an exemplary hand-securing componentthat may be used with any of the protective and exercise restraintsystems disclosed herein, as viewed from the volar or palmar side;

FIG. 4 is a schematic diagram of an exemplary hand-securing componentthat may be used with any of the protective and exercise restraintsystems disclosed herein, as viewed from the dorsal or back of handside;

FIG. 5 is a schematic diagram of a dual slat embodiment of a protectiveand exercise restraint system made in accordance with the presentdisclosure;

FIG. 6 is a schematic diagram of a single slat embodiment of aprotective and exercise restraint system made in accordance with thepresent disclosure;

FIG. 7A is a schematic diagram of a single slat embodiment of aprotective and exercise restraint system made in accordance with thepresent disclosure;

FIG. 7B is a schematic drawing of a prototype embodiment of a singleslat protective and exercise restraint system made in accordance withthe present disclosure;

FIG. 7C is a schematic detail of an upper end portion of a furtheralternative embodiment; and

FIGS. 8A and 8B are schematic diagrams of a hand strap system made inaccordance with the present disclosure.

DETAILED DESCRIPTION

Embodiments disclosed herein offer selectable levels of protectiverestraint, from liberal to intermediate exercise to strict, therebyallowing for minimal restraint necessary at each patient stage whilelimiting the range of flexion at the elbow and preventing disconnectionof tubes or lines near the face and torso or removal of the discloseddevice by a patient. This disclosure includes dual slat embodiments(see, e.g., FIGS. 1A, 1B, and 5) configured to avoid trauma to the skinof the underside of the arm or back of the hand in at-risk patients,such as from skin breakdown when used for typical lengths of timerequired for intubated patients, by providing minimal skin contact withthe arm and hand. Also disclosed are single slat embodiments (see, e.g.,FIGS. 2A, 2B, 6, 7A, and 7B) with minimal skin contact at the back ofthe hand and the side of the torso. Lastly, lateral rod embodiments aredisclosed (see, e.g., FIGS. 7A and 7B) with negligible contact witheither the arm, hand or the torso as might occur with an underside or amedial portion of an embodiment. Embodiments disclosed include handguard systems (see, e.g., FIGS. 1A-8B), which are secured in such a wayas to disallow self-removal while providing access to the back of thehand and refraining from circumferential banding. Embodiments of thedisclosed hand guard systems provide continual and instant nursingaccess to arm, wrist and back of hand intravenous or intra-arteriallines, skin assessment and nailbed circulation assessment.

Embodiments of systems disclosed may accommodate either radial or bicepsblood pressure cuffs and may include one or more of the followingfeatures or configurations: (1) may be untied from the bed or chair formaximal movement with adequate restraint and convertible to a rigidrestraint by tying to the bed or chair, further limiting movement of thearm if necessary; (2) may be attached to a bed or chair with an attachedresistance band to promote exercise, whether patient-intended or not,and/or provide an intermediate level of restraint for when neither rigidtying nor untying are appropriate; may include a squeezable exercisepalm rest and hand guard for further exercise even when rigidly tiedwhich can be removed when hand dexterity is required; (3) and/or may beutilized with most child to adult and bariatric arm sizes. Disclosedsystems allow for enhanced patient participation in early mobilization,potentially reduced sedation thereby reducing the risk of delirium whilehelping to assure that the then awake patient cannot disengage thedevice, increased thoracic exercise for diaphragmatic strength andsecretion clearance thereby hastening recovery from a ventilator andminimize pressure sores and skin breakdown, improved patientcommunication both with staff for vital symptomatic alerts, withtherapists for manual dexterity and writing, and with family andspiritual leaders for spiritual and emotional health, all in a mannerwhich reduces staff monitoring requirements for prevention ofself-extubation. Disclosed embodiments may be made from conventional andreadily available, medically-approved materials such as plastics, whichare latex-free, MRI and other diagnostic imaging-friendly, optionallydisposable, lightweight, comfortable, quickly and easily attachable anddetachable, sturdy, padded, and cleanable.

Protective and exercise restraint system made in accordance with theteachings of the present disclosure may include one or morelength-adjustable slats or rods (generally, any suitable slat, rod, orother-shaped component may be used with any one or more of the systemsdisclosed herein) with a triceps cradle or triceps strap configured tosit at the axilla and a detachable hand guard system comprising anergonomic, skin-friendly squeezable palm rest that toggles or otherwiseallows comfort and joint-protective motion of the wrist. However, thearrangement prevents patient removal of the device or of the same deviceon the opposite arm and prevents placement of the hand near a face or ofthe face near a hand to remove a tube. While primarily described hereinin the context of intubated patients, persons of ordinary skill in theart will appreciate that disclosed embodiments are equally applicablefor protection of patients who are intubated or otherwise invasivelyconnected to medical support or diagnostic devices.

Dual slat embodiments also may have a forearm cradle and facilitatefull-skin assessment and reduction of pressure sores when compared to anarm board style device. An adjustable hook and loop (e.g., Velcro™)strap may be arranged onto a hand guard system in such a way as torender the wrist available for an arterial line, the back of the handfor IV lines, and the forearm for a radial blood pressure cuff, whiledisallowing patient removal and refraining from circumferential bandingof superficial arteries. A second adjustable hook and loop strap at theupper biceps/axilla, which may attach to the triceps cradle, may securethe upper arm in the device while allowing room for a biceps bloodpressure cuff. An optional, movable, contact-free protective curvedstrap can be positioned over a desired site on the arm. The hand guardor palm rest may be removable for purposes of more complex patient taskssuch as hand communication. A moderate resistance band with bedconnector may be attached to the distal end of the slat to provideintermediate flexible restraint protection as well as exercise while aninflexible tie may be attached to the distal end of the slat to providestrict restraint protection. Different strength resistance bands may beexchanged if more intense exercise or an additional intermediate levelof restraint is desired. Non-use of the straps provides minimalrestraint protection while still providing protection fromself-extubation. Different institutions have different policies anddefinitions of a restraint and levels of restraint such that non-use ofstraps may not be considered a restraint in some instances. Institutionsalso may have different materials standards, and embodiments of thedisclosed devices are readily adapted to the use of different materials.

Turning now to the drawings, FIGS. 1A and 1B illustrate a dual slatprotective and exercise restraint system 100. As shown, two optionallyextendable slats 104 are arranged on either side of a patient's arm.Extension of slats 104 may be implemented by using a telescopingmechanism 108 that can be locked by aligning a spring-loadedball-bearing 112 disposed in an optional slat extension 116 with one oftwo or more holes 120 disposed in the slats or by using any otherappropriate mechanism. In order to affix system 100 to a patient, two ormore straps can be used. As shown in FIGS. 1A and 1B, a bicep strap 124may be attached at proximal ends 128 of slats 104. In some embodiments,bicep strap 124 may be inelastic, elastic, and/or composed of two strapsthat can be attached to one another using a hook and loop fastener 132or other appropriate type of fastener. System 100 may further include atricep strap 136, which, like bicep strap 124, may be inelastic,elastic, and/or composed of two straps that can be attached to oneanother using a hook and loop fastener 132 or other appropriate type offastener. Optional forearm straps 140 may be attached to slats 104and/or slat extensions 116, as appropriate, using any desired attachmentmechanism, such as hook-and-loop fasteners 144. Forearm straps 140, likebicep strap 124 and tricep strap 136, may be inelastic, elastic, and/orcomposed of two straps that can be attached to one another using a hookand loop fastener 132 or other appropriate type of fastener. Thepatient's hand may be restrained using a hand strap 148, which may beconnected to slats 104 and/or slat extensions 116 and/or hand guard 156,as appropriate, using any desired attachment mechanism, such ashook-and-loop fasteners 152 or tunneled slots. A hand guard 156 may bedisposed between slats 104 and/or slat extensions 116, as appropriate,using any desired attachment mechanism (e.g., bolts 160), may betelescoping, and a detachable, optional squeezable palm rest 164 may bedisposed on or around, hook and loop fastened to, molded with, adheredto, or otherwise arranged such that a patient can grip the palm restduring use without necessarily having to touch the hand guard itself,which may consist of harder materials than the palm rest. A resistanceband 168 may be attached to one or more of slats 104 and/or slatextensions 116, as appropriate, at a resistance band attachment point172, and an inflexible tie 176 may be attached to one or more of theslats and/or slat extensions, as appropriate, at an inflexible tieattachment point 180. An alternative dual slat protective and exerciserestraint system 500 is shown in FIG. 5 with only one forearm strap 140.Although inflexible tie 176 is shown as being tied to slat 104 in FIG.5, any suitable connection may be used. Further, although a loop ofmaterial is shown at the end of resistance band 168 in FIG. 5, this isonly one example of a suitable connector that would enable connection toa suitable complementary apparatus (e.g., a security cable or lockingclasp) attached to a bed, chair, or other nearby structure. Rather thanor in addition to a loop, any other suitable connection means can beused with resistance band 168 and/or inflexible tie 176. Further still,although various attachments in FIG. 5 are illustrated as nut and boltconnections, other types of connections could be used, such as hook andloop connections, buttons, or otherwise.

FIGS. 2A and 2B illustrate a single slat protective and exerciserestraint system 200. Portions of system 200 that can be implementedusing parts similar or identical to those of system 100 use the samereference numerals as are used in connection with FIGS. 1A and 1B andwill not be further described in descriptions of subsequent embodiments,as the subsequent description of FIGS. 2A and 2B and other embodimentswill focus on aspects of system 200 that differ from system 100. Asshown in FIGS. 2A and 2B, single slat protective and exercise restraintsystem 200 may include many of the same components as system 100, butmay be implemented in a single slat and/or dorsal arm rest fashion. Asbest seen in FIG. 2B, bicep strap 124 may be connected to a tricepcradle 204 at tricep cradle connecting regions 208 using appropriateattachment means, such as an adhesive and/or hook and loop fasteners. Atricep cradle extension 212 may be connected to tricep cradle 204through a telescoping mechanism 216 that can be locked by aligning aspring-loaded ball-bearing 112 disposed in the tricep cradle extensionwith one of two or more holes 220 disposed in the tricep cradle or byusing any other appropriate mechanism. Similarly, a hand guard 224 maybe connected to tricep cradle extension 212 through a telescopingmechanism 228 that can be locked by aligning a spring-loadedball-bearing 112 disposed in the hand guard with one of two or moreholes 232 disposed in the tricep cradle extension or by using any otherappropriate mechanism. An alternative single slat and/or dorsal arm restprotective and exercise restraint system 600 having a slightly differentarrangement from system 200 is shown in FIG. 6. As shown, system 600 mayinclude an axilla extension 604 and a telescoping mechanism 608 likethose described above that enables the axilla extension to be adjustedrelative to tricep cradle 212. In such an implementation, bicep strap124 may be connected to and/or fed through slots on axilla extension604. Although not shown in FIG. 6, an inflexible tie like inflexible tie176 and an attachment point like attachment point 180 may be used withsystem 600. Generally, any of the systems disclosed herein may beoutfitted with inflexible tie 176 and/or resistance band 168, asdesired.

FIGS. 3 and 4 illustrate a hand securing component 300, which may beused as part of and/or alongside a hand guard. As shown, hand securingcomponent 300 may include a squeezable palm rest 164 as well as one ormore straps 304, which may in some embodiments be the same as hand strap148. As shown in FIG. 4, one or more straps 304 may wrap around apatient's wrist and/or hand one or more times in such a way as to renderthe radial artery area unobstructed and non-compressed before beingattached to itself and/or a hand guard or palm rest using appropriatemeans, such as hook and loop fasteners, attachment points and/ortunneled slots.

FIG. 7A illustrates a single slat lateral rod protective and exerciserestraint system 700. As shown, system 700 may include a shoulder strap704, which may be inelastic, elastic, and/or composed of two straps thatcan be attached to one another using a hook and loop fastener 708 orother appropriate type of fastener. Shoulder strap 704 may be attachedto a shoulder connector 712 via one or more slots 716 and/or othermechanisms, and the shoulder connector may be mounted to an optionallyextendable rod 720 which may curve about the shoulder. The extent of rod720 from the strap connector to the straight portion of the rod may beencased in a thick cushioned sheath. Extension of rod 720 may beimplemented by using a telescoping mechanism 724 in the straight portionof the rod that can be locked in place by aligning a spring-loadedball-bearing disposed in an optional rod extension 728 with one of twoor more holes disposed in the rod or by using any other appropriatemechanism. In some embodiments, a flip lock 732 or other type of lockingmechanism may be provided separately or as a part of telescopingmechanism 724. Rod extension may be rotatably connected via rodconnector 736 to a forearm brace 740, and resistance band 168 andinflexible tie 176 may be connected to the forearm brace via attachmentpoints 172 and 180, which may be implemented as slots, hook and loopfasteners, or otherwise as appropriate. In some embodiments, resistanceband 168 and/or inflexible tie 176 may include attachment components(e.g., slots, hook and loop fasteners, buttons, or otherwise asappropriate) that can be secured to a patient's bed or chair or othernearby and at least similarly relatively immobile structure. Forearmbrace 740 may be rotatably connected via a wrist pivot connector 744 toa wrist brace 748, and the wrist brace may include one or more slots 752or other mechanism(s) suitable for securing hand strap 148 to the wristbrace. Although wrist strap 148 is shown in FIG. 7A as having across-over point near the anatomical snuff box, the cross-over point mayinstead be located at the front of the volar aspect of the wrist, i.e.,along the right side of the wrist shown in FIG. 7A. Further, in someembodiments, wrist strap 148 may connect to bolt 160 or squeezable palmrest 164 and/or a support structure therefor using appropriateconnection means rather than or in addition to extending through slot752. In some embodiments, a hand guard, squeezable palm rest, and/orother components located near the hand of systems disclosed herein maybe detachable and/or rotatable such that the hand-related components ofa system like system 700 can be removed or rotated, the remainder of thedevice flipped over along its longitudinal axis, and the hand-relatedcomponents reattached if they were removed instead of being rotated,such that a system like system 700 can be adapted for use with a rightarm or left arm.

In some embodiments where both arms of a patient are protected withsystems disclosed herein, one or more protective chest straps and/orback straps (not shown) may cross in front of (e.g., across or adjacentthe nipples) and/or behind the patient to constrict relative movement ofthe two systems. In some embodiments, the chest and/or back straps mayextend across the torso parallel to one another; however, one or more ofthe chest and/or back straps may additionally or alternatively beconfigured to cross one another, where necessary and/or appropriate. Forexample, when two systems like system 700 are used to protect a patient,a chest strap may join the systems through attachment to a shoulderstrap like shoulder strap 704 of each system (left and right arms). Insome embodiments, a shoulder or back strap may comprise hook and loopmaterial, buttons, or other connection devices such that the chest orback strap can be connected to a shoulder strap like shoulder strap 704or any other appropriate portion of one or more of the systems disclosedherein. In some embodiments, chest and/or back straps may be permanentlyaffixed to one or more of the systems disclosed herein such that thesystems can be attached to each other using one or more of the chestand/or back straps, e.g., using hook and loop or other appropriatefasteners to connect chest straps together and/or back straps together.It may be preferable with some embodiments and/or certain patients notto utilize a back strap as described above because it may contribute tocreation of pressure sores and may not help to prevent the restraintfrom rolling under the back of the patient.

In some embodiments, shoulder connector 712, rod 720, rod extension 728,forearm brace 740, and/or wrist brace 748 may comprise a singlerestraining structure, such as a rod, bar, or slat, which may curve andslope medially and downward from the forearm brace portion of thestructure toward the wrist brace portion of the structure such that theforearm brace portion of the structure may be inches higher than andlateral to the outermost portions of a patient's arm. That is, with apatient's arm having system 700 attached thereto and resting on asurface as shown in FIG. 7A, wrist brace 748 or a wrist brace portion ofa structure made in accordance with an embodiment that combines one ormore of rod 720, rod extension 728, forearm brace 740, and/or wristbrace 748 into a single structure, may be rigid and may extendvertically and laterally away from the patient's hand and squeezablepalm rest 164 (e.g., such that at least half of the structure ispositioned vertically above a horizontal plane passing through thepatient's arm). In some embodiments, rod 720, forearm brace 740, and/orwrist brace 748 may comprise and/or be enclosed by a thin or thickpadded sheath, as may any one or more of the other components describedin this disclosure. In some embodiments, rod 720, or a structure made inaccordance with an embodiment that combines one or more of rod 720, rodextension 728, forearm brace 740, and/or wrist brace 748 into a singlestructure, may curve laterally around the patient's shoulder such thatshoulder strap 704 may extend across the clavicle, optionally forming aright angle with at least one surface of the clavicle. In someembodiments, such a structure or combination of components may onlycurve away from the wrist as described above with the remainder of thestructure or combination of components forming a substantially straightor slightly curved line (optionally similarly to a windsurfing boom, andoptionally crossing the shoulder or bending around the shoulder relativeto a front view of the patient).

As shown in FIG. 7C, an alternative shoulder connector 756 functionallysimilar to shoulder connector 712, and an alternative rod 760 like rod720, may comprise a single piece of material. Shoulder strap 704 may beconnected to an upper end of alternative shoulder connector 756 usingsuitable connection means (e.g., a slot and/or hook and loop fastener)such that the shoulder strap may extend across the clavicle, optionallyforming a right angle with at least one surface of the clavicle. As alsoshown in FIG. 7C, a shoulder pad 764 may be affixed to, built into, orotherwise associated with alternative shoulder connecter 756 to preventthe alternative shoulder connector from directly abutting the patient'sskin, getting lodged under the patient's shoulder, or, in some cases,riding up on top of the patient's shoulder, although in other cases theconnector may be allowed to ride up on top of the patient's shoulder(depending on the patient's condition). Shoulder pad 764 may compriseany suitable material and may have any appropriate shape, optionallyeither contoured to the patient's shoulder or simply a cylindrical padsurrounding alternative shoulder connector 756, provided that itprevents the alternative shoulder connector from directly abutting thepatient's skin, getting lodged under the patient's shoulder, or, in somecases, as noted above, riding up on top of the patient's shoulder.Although shoulder pad 764 is shown in FIG. 7C attached to alternativeshoulder connector 756, it may be used with other components and/ordevices disclosed herein, such as rod 720, shoulder connector 712, slats104, and/or tricep cradle 204, among others. Shoulder pad 764 ispreferably configured so that it will not be in contact with or pressagainst the patient's skin, unless the patient strains against it orotherwise moves so that the shoulder pad is forced into contact with theskin despite being initially attached in such a way that it does nottouch the skin. In some embodiments, shoulder pad 764 may be arrangedsuch that it is separated from a patient's skin by one inch, give ortake a centimeter, when the patient is at rest. In some embodiments,systems disclosed herein may also be arranged such that no component ofthe system comes within one inch, give or take a centimeter, from thepatient's bed, chair, or other support structure when the patient is atrest. In some embodiments, all of the straps used to connect a systemimplemented in accordance with the present disclosure should only beloosely connected to the patient so as to allow underneath it theinsertion of one to two fingers to prevent unnecessary pressure sores;however, with some patients, it may be necessary to tighten the strapsin order to prevent the patient from removing the system or otherwisecircumventing one or more of its protective functions. Generally,systems disclosed herein may be arranged such that only a wrist strap orhand strap system and shoulder strap touch a patient's skin after beingarranged properly on the patient while the patient is at rest.

FIG. 7B illustrates a single slat or lateral rod protective and exerciserestraint system 800 similar to system 700. As shown, system 800 omitsvarious elements of system 700 and provides sturdier, nonrotatableconnections, which may be appropriate under certain conditions. Insystem 800, like in system 700, extendable rod 720 and optional rodextension 728 are joined with a telescoping mechanism 724. However,unlike system 700, in system 800, rod extension 728 is connecteddirectly to a nonrotatable wrist brace 804 (e.g., using bolt 808 orother appropriate connector), which may include one or more slots 752enabling connection of hand strap 148 at one or more locations along thenonrotatable wrist brace. Similarly, slots 752 enable connection of aresistance band and/or inflexible tie, as desired, at one or morelocations along nonrotatable wrist brace 804. More or fewer slots may beused and/or different connection means may be used, such as hook andloop connectors or others known in the art. In some embodiments, handstrap 148 may connect to squeezable palm rest 164 or a support structurethereof, which may be identical or similar to hand guard 156 of FIG. 1A.

Although relatively wide straps are shown in FIG. 7B, thinner straps maybe used, as appropriate. Generally, under ideal conditions, a systemlike system 700 or system 800 should only touch a patient's skinintermittently at a minimal number of points, such as at the locationsof one or more loose straps so as to allow underneath it the insertionof one to two fingers, while other portions of the system, such as rod720, rod extension 728, forearm brace 740, wrist brace 748, and/ornonrotatable wrist brace 804, should be arranged such that they do nottouch the patient's skin.

FIGS. 8A and 8B illustrate a hand strap system 900 that can be used withone or more of the other systems disclosed herein. Hand strap system 900may include three straps, although in some embodiments these straps maybe manufactured as a single, tripartite strap. As shown in FIG. 8A, afirst wrist (or hand) strap 904, a second wrist (or hand) strap 908, anda thumb strap 912 may extend from a connection point 916, which maycomprise a grommet or other connection element suitable for connectionto a hand guard, wrist brace, or other suitable component of one or moreof the other systems disclosed herein. In some embodiments, more thanone connection point may be used, such that first and second wriststraps 904, 908 connect to a first connection point and thumb strap 912connects to a second connection point. Further, in some embodiments,first wrist strap 904, second wrist strap 908, and thumb strap 912 mayall connect to their own connection points on one or more portions ofthe other systems disclosed herein. As shown in FIG. 8B, in someembodiments, first and second wrist straps 904, 908 may be affixed toone another behind the wrist using hook and loop fasteners, although anysuitable connection may be used. In some embodiments, first and secondwrist straps 904, 908 may be implemented as a single, optionallyslightly elastic strap (such that the strap can be placed around thepatient's hand but static enough that none of the protective functionsof the overall system with which it is used are compromised). As shownin FIGS. 8A and 8B, thumb strap 912 may be wrapped around the patient'sthumb and attached to first wrist strap 904 between the lateral aspectof the wrist and a connection point for attaching the first wrist strapto a component of one or more of the other systems disclosed herein,such as connection point 916. Generally, thumb strap 912 may be attachedto first wrist strap 904 anywhere along the volar aspect of the wrist orhand with a hook and loop connection or other suitable connection.

In some embodiments, a hand guard of a sturdy material may attach to awrist brace portion, a rod, forearm brace, and/or a slat like one ormore of those disclosed herein. The hand guard may contain one or moreattachment points at its volar surface for one or more wrist straps likefirst and second wrist straps 904, 908 and thumb strap 912, which maycomprise hook and loop material. The medial wrist strap may coursecephalad and medially while the lateral wrist strap may course cephaladand laterally, each to loosely attach, so as to allow underneath it theinsertion of one finger, to each other by hook and loop or othermechanism at the dorsal aspect of the wrist. Thumb strap 912 may coursefrom the volar aspect of the hand guard across the anatomical snuff boxtoward the posterior aspect of the thumb, then toward the anteriorthenar eminence, and loosely attach, so as to allow underneath it theinsertion of one finger, to the lateral wrist strap by hook and loop orother mechanism. The hand guard may optionally be covered by adetachable squeezable ovoid palm rest poised to render the hand andwrist in a non-stressed position using hook and loop or other means ofdetachably fastening to the hand guard while not obstructing the wristand thumb straps or their attachment points.

A loose shoulder strap allowing the insertion underneath same of one totwo fingers like shoulder strap 704 and a restraining structurecomprising, e.g., shoulder connector 712, rod 720, rod extension 728,forearm brace 740, and/or wrist brace 748, or a single restrainingstructure, such as a rod, bar, or slat that does not touch the arm mayallow enough elbow movement that a patient will not endure any jointdamage from heterotopic ossification or contractures while also guardingagainst nerve palsies at the shoulder area and disallowingself-extubation as well as providing full skin access. One or more loosestraps at the hand allowing insertion underneath same of one finger,such as straps 904, 908, and 912, may allow enough movement at the wristand fingers for the same reasons while disallowing device removal. Skincan be torn as a result of edema without anything resting on the skin,and minimal contact between devices disclosed herein and a patient'sskin is very important. The shape of a restraining structure like thatshown in FIG. 7A curving laterally and upward relative to a patient'shand and/or arm may allow a hand to swell without meeting the resistanceof a hard component of device (e.g., wrist brace 748). The position of arestraining structure like that shown in FIG. 7A being higher than thearm when the patient is lying at rest on a bed with their arms at theirsides allows the arm to bend without having constant contact with thedevice. Padding at the shoulder, such as shoulder pad 764, allows thedevice to be far enough away from the arm, even in a bariatric patient,that skin contact can still be minimized. A thin padded sheath aroundthe major components of the device (e.g., shoulder connector 712, rod720, rod extension 728, forearm brace 740, and/or wrist brace 748, or asingle restraining structure, such as a rod, bar, or slat) may protectthe patient from any intermittent contact with the device and mayprotect staff who might be hit with the device from injury. An optionalchest strap may help position the device to prevent it from making itsway to the underside of the supine patient. Although a back strap may becontraindicated for reasons stated above, i.e., to avoid skin pressureand keep the restraining structure away from the underside of thepatient, a back strap may nonetheless be used where the material is thinand/or nonabrasive or where a patient is otherwise able to disengagethemselves from the device.

In one example of use of disclosed embodiments, a medical staff personplaces the patient's arms in protective and exercise restraint systemslike those described herein (one per arm) with the palm adjacent thehand guard and touching the squeezable palm rest and the uppermost armarea in a triceps cradle, which may abut the axilla. The biceps strapshould be secured so as not to hinder circulation. The hand strap, whichmay be attached to the hand guard, may then be secured by starting atthe base of the 5^(th) finger anteriorly toward the area below the thumb(thenar eminence), then around the back of the wrist and onto thehypothenar eminence, then crossing anteriorly in an upward diagonaldirection toward the area just above the thumb, where it may then besecured to another point on the hand guard. One or more optional forearmstraps may be secured in various positions, assuring clearance of anyIVs. Depending on the level of restraint ordered and the desire formovement and exercise, either no bed tie, or the resistance band, theinflexible tie, or both may be attached to the patient's bed or chair.The level of restraint can be easily selected and changed depending uponthe patient's changing needs. Whether tied or untied, the patient canneither reach tubes and lines near the torso and face nor remove thedevice itself. Movement and exercise are encouraged by the resistanceband and the squeezable palm rest. After reading this disclosure in itsentirety, those of ordinary skill in the art will understand that,although particular uses of particular devices are described in thisparagraph and throughout the disclosure, various other similar uses ofvarious other devices taught and disclosed herein may be used.

As may be apparent to persons of ordinary skill, embodiments of thedisclosed systems allow for three or more levels of restraint, all ofwhich prevent the awake and so-inclined subject from disengaging fromthe restraint or approximating the face and hand, including oneconfiguration for resistance exercise therapy. Other advantages of thedisclosed systems include providing a safe level of freedom and exercisewhile preventing self-extubation and self-removal even by the agitatedor determined patient, providing continual access to forearm and back ofhand intravenous lines and wrist arterial lines and for skin assessment(full visualization of the back of the arm and hand allowed by dual slatand lateral rod models with reduction of pressure ulcers andvisualization of the back of the hand with the single slat model) withsimultaneous prevention of the agitated patient from disengaging thehand and subsequently the restraint on the opposing arm even while inthe untied, more liberal configuration. Disclosed systems also allowmovement of fingers and thumbs, rotation of the wrist, a small amount ofbending at the elbow, and full range of motion at the shoulder for jointprotection.

Embodiments of the systems disclosed are length adjustable andconfigured to accommodate most arm widths, thereby allowing space forseparate radial and biceps blood pressure cuffs in patients who mightotherwise not have room. The system may be quickly converted to three ormore levels of restraint, and affords 360 degree skin assessment andreduced risk of pressure sores of the underside of the arm or back sideof the hand (dual slat and lateral rod models) or of the back of thehand solely (single slat model) or has an exercise modality (resistanceband and squeezable palm rest) or quickly and easily interchange betweenthree or more levels of restraint.

Further features of the disclosed systems include: (1) securable atthree or more levels of hand and arm restraint (i.e. “secure tri-pluslevel restraint”); (2) secure tri-plus level hand and arm restraintsystem with an anxiety-reducing intermediate movement and exerciseconfiguration that allows mobility and resistance exercise therapy atmultiple levels which can be utilized when the untied (to the bed orchair) state is too risky and the inflexible tie (to the bed or chair)is too strict or anxiety provoking and/or if the patient can exercise,whether knowingly or unknowingly in order to accommodate theever-changing needs of the intubated patient promoting minimal levels ofboth restraint and sedation necessary while disallowing self-removal bythe so-intentioned patient; (3) secure tri-plus level hand and armrestraint system with removable exercise hand guard system includingsqueezable ergonomically-shaped exercise palm rest; (4) hand and armrestraint system with a hand guard that toggles to allow moderatebilateral sideways rotation of the wrist for comfort and jointprotection; (5) secure tri-plus level hand and arm restraint systemwhich by its hand guard design disallows self-removal of the fingers andhand by the fully awake and so-intentioned patient for interference withlines and tubes even when not tied to the bed or chair therebydisallowing self-extubation and assuring minimized sedation without fearof disengagement of the device; (6) secure tri-plus level hand and armrestraint system with continual visibility of back of the handintravenous line sites; (7) secure tri-plus level hand and arm restraintsystem with lack of circumferential banding and continual visualizationof and non-interference with wrist arteries and arterial line sites; (8)secure hand and arm restraint system with minimization of skin contactof the underside of the arm with the dual slat and lateral rod modelsfor non-interference with skin integrity and continual assessment; (9)secure hand and arm restraint system with room for the patient tostraighten and bend the arm slightly at will for comfort in the dualslat and lateral rod models; and (10) utilize a strapping techniquewhich is loose and only intermittently makes skin contact to reduce therisk of pressure ulcers and nerve palsies.

Using systems disclosed herein, a single device may be effectivelyemployed for all levels of restraint that may be desired throughout apatient's changing status thereby always promoting minimal restraintnecessary. Disclosed systems provide unique features that preventself-extubation while not strapped to a bed or chair for an awake andat-risk patient who might otherwise wriggle out of a palm strap, andencourage early mobilization and exercise promoting the strengthrequired for advancement from a ventilator. The dual slat and lateralrod embodiments do not obscure the underside of the arm thereby reducingthe risk of pressure sores and skin breakdown. Dual slat, single slatand lateral rod embodiments expose the back of the hand for intravenouslines, also optimizing skin integrity in this area. The lateral rodmodel exposes the back of the hand, underside of the arm and the medialaspect of the arm which abuts the torso. The multiple degrees ofincreased freedom of movement provided by disclosed systems allow forreduced patient agitation and therefore sedation medication may bedecreased and minimized which in turn promotes increased patientcognition and thereby would be more likely to reduce the incidence ofdelirium and post-intensive care syndrome, a form of PTSD. Once apatient-appropriate restriction configuration is in place, direct nurseor sitter monitoring may not be necessary whereas untying the restraintscurrently available without constant 1:1 supervision invitesself-extubation.

Experimental Results

Prototypes of the dual and single slat embodiments, shown in FIGS. 5, 6,and 7 were tested on male and female test subjects under simulatedclinical conditions. The prototypes shown in FIGS. 5 and 6 were placedon awake male and female non-intubated healthy subjects ranging in agefrom 35-80 and heights of 5′2″ to 6′. During this testing it wasdetermined that in the untied state, the lack of arm flexion afforded bythe upper biceps or triceps strap and cradle securing against theaxilla, together with the hand guard system securing the hand in place,made objects placed on the face and torso of the subjects unreachable.With the palm secured in the hand guard system, the hand could not bedisengaged and the opposing arm restraint was unable to be removed. Ablood pressure cuff was able to be placed on the subjects' arms. Thetested devices were adjustable, accommodating the variable arm lengthsin this height category for these subjects. Non-circumferential bandingat the wrist did not interfere with circulation. In the resistance bandtie configuration, exercise was possible by moving the arms withoutbeing able to reach an object placed on the face or torso. In theinflexible tie configuration, exercise was possible by squeezing thepalm rest. The device was described by test subjects as beingcomfortable.

Further Embodiments and Considerations

The foregoing has been a detailed description of illustrativeembodiments of the invention. It is noted that in the presentspecification and claims appended hereto, conjunctive language such asis used in the phrases “at least one of X, Y and Z” and “one or more ofX, Y, and Z,” unless specifically stated or indicated otherwise, shallbe taken to mean that each item in the conjunctive list can be presentin any number exclusive of every other item in the list or in any numberin combination with any or all other item(s) in the conjunctive list,each of which may also be present in any number. Applying this generalrule, the conjunctive phrases in the foregoing examples in which theconjunctive list consists of X, Y, and Z shall each encompass: one ormore of X; one or more of Y; one or more of Z; one or more of X and oneor more of Y; one or more of Y and one or more of Z; one or more of Xand one or more of Z; and one or more of X, one or more of Y and one ormore of Z.

Various modifications and additions can be made without departing fromthe spirit and scope of this invention. Features of each of the variousembodiments described above may be combined with features of otherdescribed embodiments as appropriate in order to provide a multiplicityof feature combinations in associated new embodiments. Furthermore,while the foregoing describes a number of separate embodiments, what hasbeen described herein is merely illustrative of the application of theprinciples of the present invention. Additionally, although particularmethods herein may be illustrated and/or described as being performed ina specific order, the ordering is highly variable within ordinary skillto achieve aspects of the present disclosure. Accordingly, thisdescription is meant to be taken only by way of example, and not tootherwise limit the scope of this invention.

Exemplary embodiments have been disclosed above and illustrated in theaccompanying drawings. It will be understood by those skilled in the artthat various changes, omissions and additions may be made to that whichis specifically disclosed herein without departing from the spirit andscope of the present disclosure.

What is claimed is:
 1. A medical protective and exercise restraintsystem, comprising: a rigid restraining structure configured anddimensioned with a length sufficient to extend from a patient's hand tothe patient's shoulder with the patient's elbow unbent; a hand strapattached to the restraining structure adjacent the patient's restrainedhand, configured to be wrapped around the patient's hand or wrist; ashoulder strap attached to the rigid restraining structure adjacent thepatient's shoulder; configured to be wrapped around the patient's upperarm or axilla; and a squeezable, ovoid palm rest attached to the rigidrestraining structure adjacent the patient's hand; wherein said rigidrestraining structure is configured to bear against the patient only attwo locations; a first location at the shoulder and a second location atthe hand; and wherein the hand strap and shoulder strap is configured toconstrict movement of the patient's arm such that the patient is unableto touch the restrained hand to their face.
 2. A medical protective andexercise restraint system according to claim 1, further comprising athumb strap attached to the rigid restraining structure adjacent thepatient's hand, wherein the thumb strap is configured and dimensioned toattach to the hand strap along the volar aspect of the patient's wristor hand.
 3. A medical protective and exercise restraint system accordingto claim 1, further comprising an inflexible tie attached to the rigidrestraining structure and configured for attachment to a patient supportstructure.
 4. A medical protective and exercise restraint systemaccording to claim 1, further comprising a resistance band attached tothe rigid restraining structure and configured for attachment to apatient support structure.
 5. A medical protective and exerciserestraint system according to claim 1, further comprising paddingaffixed to the shoulder strap or to the rigid restraining structureadjacent the patient's shoulder.
 6. A medical protective and exerciserestraint system according to claim 1, wherein the rigid restrainingstructure includes a telescoping mechanism operable to modify the lengthof the restraining structure.
 7. A medical protective and exerciserestraint system according to claim 1, further comprising a hand strapsystem attached to the rigid restraining structure adjacent thesqueezable palm rest.
 8. A medical protective and exercise restraintsystem according to claim 1, wherein attachments of the rigidrestraining structure to the patient consist of said shoulder strap andsaid hand strap.
 9. A medical protective and exercise restraint system,comprising: a rigid restraining structure configured and dimensionedwith a length sufficient to extend from a patient's hand to thepatient's shoulder with the patient's elbow unbent; a hand strapattached to the rigid restraining structure adjacent the patient'srestrained hand, configured to be wrapped around the patient's hand orwrist; a shoulder strap attached to the rigid restraining structureadjacent the patient's shoulder, configured to be wrapped around thepatient's upper arm or axilla, a graspable member at the palm whereinthe graspable member comprises a squeezable, ovoid palm rest attached tothe rigid restraining structure; wherein the hand strap and shoulderstrap constrict movement of the patient's arm such that the patient isunable to touch the restrained hand to their face; wherein said rigidrestraining structure is configured to bear against the patient only attwo locations; a first location from the bicep to the shoulder and asecond location at the hand.
 10. A medical protective and exerciserestraint system, comprising: a single rigid lateral rod with anextendable length configured to extend from just below a patient'shoulder to the patient's hand with the patient's elbow in asubstantially straight position; a nonrotatable wrist brace disposed atthe distal end of said rod, said wrist brace having one or more slots; ahand strap extending through said one or more slots for securing thepatient's hand to the wrist brace in a manner that permits rotation ofthe patient's wrist without rotation of the nonrotatable wrist brace; asqueezable palm rest securable to the hand strap; and an arm strapconnected to said rod at an end opposite the wrist brace and configuredto secure said rod to the patient's arm adjacent the shoulder; whereinsaid system is configured to contact the patient's arm at only twopoints such that no components of the system contact the patient's armbetween the hand strap and arm strap.